Navigation

MFDS Expands Minor Changes Exempt from Pre-Approvals

Korea’s main regulatory body, the Ministry of Food and Drug Safety (MFDS), expanded its qualifications for what is classified as an “exempt medical device.” This amendment was made to conserve the time and resources wasted on accounting for changes that have insignificant impacts on the safety and efficacy of a medical device.

Under the new regulations, the MFDS has included more changes to be added to the list of “exempt minor changes” that have little to no effect on the safety and performance of a medical device, such as deletion of a product name, change in location of the power switch, correction of an insignificant typographical error, among other additions. The manufacturer/importer will still need to report the change to the MFDS via an online system, but a file for approval will not be necessary.